FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below UPN: M00547340
- Recall number
- Z-2674-2017
- Recalling firm
- Boston Scientific Corporation
- Product
- Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below UPN: M00547340
- Status
- Terminated
- Initiated
- 2017-06-01
- Posted
- not on file
- Terminated
- 2018-06-26
- Reason
- Label on the affected devices incorrectly identifies the injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be above the balloon
- Root cause
- Employee error
- Action
- Boston Scientific Notifications to US consignees sent via Federal Express Priority mail on June 1, 2017. The notification instructs the account to check inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. Contact: Brendan Smith, Boston Scientific Quality Systems, 763-494-1133 BSCFieldActionCenter@bsci.com.
- Quantity
- 32 units
- Distribution
- MI, MO Foreign: Austria France Great Britain Italy Spain Sweden
- Lot, serial or model codes
- Lot Number: 19343209 Exp: 6/3 0/2018
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FGE
- Firm FEI
- 3005099803
- Firm city
- Marlborough
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28